Packages for intravenous infusions or instillations are known, which comprise a flexible bag in which a chamber for containing a diluent is formed, and from which a flexible tube with an openable closure extends, equipped with a coupling and perforation device, through which a pharmaceutical or nutritional substance in powder, gel or other forms is withdrawn from a bottle and inserted into the inner chamber of the bag, which substance, once mixed with the diluent, forms the medicament or nutrient to be supplied to the patient.
It is increasingly required that the inner chamber of the flexible bag is made completely sterile. This is obtained by using machines which carry out the operations of filling and closing the bag in a sterile environment.
However, the problem of ensuring sterility conditions even when the bottle containing the medicinal or nutritional substance in powder is coupled to the tube extending from the flexible bag still remains.
By manually maneuvering the bottle and the tube, as currently occurs, a loss in sterility is inevitable, and in the case of particular high-risk drugs, this loss may lead to severe effects for both the patient and the medical and healthcare personnel responsible for the patient care.
First, there is the risk that an incorrect administration is performed, for example due to a premature or erroneous triggering of the drug reconstitution.
As it has been explained in the literature, the pharmacological therapy comprises the whole “chain” of the drug, i.e., all those actions and processes which are implemented to carry out the pharmacological therapy: this is a basic, crucial element of the health care.
A study dated 2003 (Taxis, 2003) showed, by directly observing the infusion therapy practice, that 73% of infusions are performed too fast, and that errors in the preparation occur in 14% of cases.
The most common errors are of various types: jeopardized sterility of the products to be mixed, unreadable writing of the data about the drug to be reconstituted on the infusion container, wrong cocktails of drugs, errors during the administration, etc.
With regard to potential risks for physicians, healthcare assistants, pharmacists, etc., the current drug reconstitution procedures include the use of special rooms equipped with protection systems (laminar flow hoods) and the personnel is subjected to strict safety measures. However, in the hospital facilities, pharmacists, physicians, healthcare assistants and other healthcare operators are subjected to a severe hazard for their health and reproductive capacity on a daily basis, often without even noticing it. Although the hazardousness of chemotherapy, antiviral drugs, antibiotics, hormones and other drugs is well characterized, estimation by the USA federal government confirm that over 5.5 million healthcare operators continue to be dangerously exposed to such substances every year.
Traces of hazardous drugs have been found on power outlets, chairs and tables, floors, and not only in hospital pharmacies, but also in patient rooms and other spaces intended to such pharmaceutical preparations.
Furthermore, several studies showed the presence of residues of hazardous drugs in the urine of the personnel responsible for the reconstitution of drugs.